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in front of a computer screen, a hand holds a phone that displays Neuralink's logo – coverage from STAT

Neuralink can now study its brain implant in humans, but it’s still catching up to its peers

May 26, 2023... Neuralink, however closely watched, is still catching up to its peers in the neurotechnology field. 

Colorful illustration of three seniors sitting on top of a large vaccine syringe and surrounded by abstract circles – public health coverage from STAT

Science finally figured out how to make effective RSV vaccines. Will seniors care?

May 26, 2023... A host of hurdles threaten to hinder the use of newly developed RSV vaccines for older adults.

Brett Guthrie gestures while speaking in a conference room – coverage from STAT

Will Medicare cover it? Drugs like Aduhelm are challenging its standard

May 25, 2023... Medicare’s coverage decision has revived longstanding questions about how the federal program determines whether it will pay for new drugs and devices.

Illustrations of lungs. A mother holds her infant child on the right side of the lungs and left lungs show different RSV treatments -- health coverage from STAT

We’ll soon have tools to protect infants against RSV. Can we put them to good use?

May 24, 2023... Medical professionals who care for kids are ecstatic they may soon have tools to prevent RSV. They are also aware of the challenges ahead.

tobacco cigarette nicotine

Achieve Life Sciences drug helps smokers quit in trial but would face stiff competition if approved

May 23, 2023... In a trial, Achieve's cytisinicline helped smokers quit without major side effects. But if approved it would face stiff competition from varenicline.

OpenAI logo reflected to another surface from a phone screen – first opinion coverage from STAT

Three ways to test medical AI for safety

May 23, 2023... The biggest challenge of using generative AI in medicine is the hallucination problem, in which the system just makes things up.

Liver illustration

FDA advisers vote against approving Intercept’s NASH drug

May 19, 2023... A panel of expert advisers to the FDA voted against approving Intercept Pharmaceuticals’ investigational treatment for NASH, a prevalent liver disease with no available medicines.

Pharmalittle: AstraZeneca plans to ‘love’ China’s Communist Party; U.S. Supreme Court rules against Amgen in patent case

May 19, 2023... The U.S. Supreme Court upheld a ruling that Amgen failed to disclose sufficient information about patent claims for its cholesterol drug Repatha.

FDA advisory panel backs Pfizer’s RSV vaccine, but expresses some safety concerns

May 18, 2023... A committee of vaccine experts voted to recommend the FDA approve Pfizer’s maternal RSV vaccine, though some members expressed safety concerns.

Pharmalittle: Appellate judges appear skeptical of FDA decisions on abortion pill; FTC widens probe into PBMs

May 18, 2023... A federal appeals court panel heard arguments in a case that could determine the future of a commonly used abortion pill.

Illustration of Paul Stoffels extinguishing a flaming pile of money with a firehose – biotech and pharma coverage from STAT

In Belgium, a native son returns to resurrect the drugmaker Galapagos — and ‘to get the trust back’

May 18, 2023... There is, according to Wall Street, no worse investment in biotech than Galapagos NV. But a new team is seeking to mount a turnaround.

Mifepristone (Mifeprex) and Misoprostol

Federal judges question FDA authority in abortion pill hearing

May 17, 2023... Federal judges questioned the FDA's authority during an appeals court hearing over the agency's approval of the abortion pill mifepristone.

Pharmalittle: FTC suit over Amgen spotlights ‘bundling’ deals with insurers; FDA staff says Pfizer RSV vaccine is effective

May 17, 2023... The FTC's suit to block Amgen from acquiring Horizon Therapeutics cast a spotlight on a practice known as bundling.

Human Respiratory Syncytial Virus (RSV)

Pfizer RSV vaccine seen as effective against severe disease, FDA documents say

May 16, 2023... An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the FDA said.

an pharmacist stands next to an assembly lines at a drug manufacturing unit – first opinion coverage from STAT

The U.S. needs to pressure India to improve drug safety

May 16, 2023... The situation will only improve under international pressure from countries that are importing drugs from India.

Pharmalittle: FDA OKs new kind of drug to treat hot flashes; Alzheimer’s drug could cost Medicare up to $5 billion a year

May 15, 2023... The FDA approved a new kind of drug to treat hot flashes, which could offer relief to women who do not want to take hormone therapy.

Cambridge: Sarepta

FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne

May 12, 2023... A panel of independent advisers to the FDA narrowly voted 8 to 6 to recommend accelerated approval for Sarepta’s gene therapy for Duchenne muscular dystrophy.

Pharmalittle: U.S. Senate committee passes PBM bills; Pfizer CEO predicts pharma will sue over Medicare price negotiations

May 12, 2023... The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers.

Sarepta - Cambridge -AP

Tracking the FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy

May 12, 2023... We're live-blogging today's FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy.

Glioblastoma Cells

An ultrasound device may unlock brain cancer treatment, early study shows

May 12, 2023... It's difficult for chemotherapy treatments to cross the blood-brain barrier. In a small study, a new implantable ultrasound device shows promise in doing so.

Health insurance illo

A former health insurance executive turns to tech to make claims less of a nightmare

May 11, 2023... Former Elevance executive Rajeev Ronanki has taken over as CEO at Lyric, where he wants to transform the confusing world of insurance claims with tech.

Pharmalittle: FDA panel recommends first OTC birth control pill; Senate hearing on insulin costs satisfies no one

May 11, 2023... An advisory panel of independent experts voted unanimously that the FDA should approve the first over-the-counter birth control pill.

How the FDA’s pandemic flexibilities boosted mental health apps — and what happens now

May 11, 2023... The FDA's pandemic flexibilities gave a major boost to mental health apps. What happens now?

Suzan DelBene

Lawmakers press CMS to release new breakthrough device coverage rule

May 10, 2023... Lawmakers echoed device makers' call for an easier pathway to CMS reimbursement of medical device breakthroughs at a congressional hearing Wednesday.

Pharmalittle: Gilead wins lawsuit against HHS over HIV pill patents; most Americans say abortion pill should remain on the market

May 10, 2023... Gilead Sciences prevailed in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills.

FDA reviewers had string of concerns about Sarepta’s gene therapy for Duchenne, documents show

May 10, 2023... Reviewers at the FDA concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns.

The FDA building -- First Opinion coverage from STAT

What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history

May 9, 2023... The FDA has found that a Sun Pharmaceuticals facility in India failed to comply with a legal mandate to correct serious shortcomings.

-- coverage from STAT

4 ways the health care system should shift its thinking on AI, according to experts

May 5, 2023... “People are thinking of ChatGPT as like a box. The progress in the field has not been this box,” one expert said at #STATBreakthrough. It's all the technology inside it.